Intra uterine device

Abstract

The present invention discloses an Intra Uterine Ball (IUB) device useful for a gynecological procedure or treatment. The aforesaid device comprises a hollow sleeve for at least partial insertion into the uterine cavity; and, an elongate conformable member with at least a portion comprised of shape memory alloy. The elongate member is adapted to be pushed out from said sleeve within said uterine cavity. It is the core of the invention that the elongate member is adapted to conform into a predetermined three dimensional ball-like configuration within said uterine cavity following its emergence from said sleeve, such that expulsion from said uterine cavity, malposition in said uterine cavity, and perforation of the uterine walls is prevented.

The invention claimed is: 
     
       1. An intra uterine device comprising an elongate conformable member with at least a portion including a contraceptive agent having shape memory adapted to conform into a predetermined three dimensional configuration formed by at least two loop-like structures approximately perpendicular with respect to each other when released from a hollow sleeve positioned within a uterine cavity, wherein a first plane defined within a first loop-like structure crosses through a second and approximately perpendicular plane defined within a second loop-like structure, and wherein said three dimensional configuration is capable of elastically contracting and expanding in response to contraction and expansion of said uterine cavity thereby enabling said three dimensional configuration to maintain its position within said uterine cavity, wherein the elongate conformable member has a proximal end and a caudal end and is configured to be linearized in the hollow sleeve into a single straight elongate conformable member having the proximal end at one end of the sleeve and the caudal end at the other end of the sleeve and is configured to be introduced from the sleeve into the uterine cavity to assume the predetermined three dimensional configuration. 
     
     
       2. The intra uterine device of  claim 1 , wherein said at least said portion having said shape memory is configured to fold into only two loop-like structures. 
     
     
       3. The intra uterine device of  claim 2 , wherein said elongate conformable member is composed of Nitinol. 
     
     
       4. The intra uterine device of  claim 1 , wherein said three dimensional configuration has a diameter of about 10 mm to about 15 mm. 
     
     
       5. The intra uterine device of  claim 1 , wherein said contraceptive agent is copper or a contraceptive hormone. 
     
     
       6. The intra uterine device of  claim 1 , wherein said three dimensional configuration facilitates release of said contraceptive agent into said intrauterine cavity in a uniform manner. 
     
     
       7. The intra uterine device of  claim 1 , wherein the device consists essentially of the elongate conformable member and wherein the three-dimensional configuration is ball-like in shape. 
     
     
       8. A method of contraception comprising: (a) providing an elongate conformable member including at least a portion having a shape memory adapted to conform into a predetermined three dimensional configuration formed by at least two loop-like structures approximately perpendicular with respect to each other, wherein a first plane defined within a first loop-like structure crosses through a second and approximately perpendicular plane defined within a second loop-like structure, said elongate member including a contraceptive agent, wherein the elongate conformable member has a proximal end and a caudal end; and (b) delivering said elongate member through a hollow sleeve into a uterine cavity to thereby form said three dimensional configuration in said uterine cavity wherein the elongate conformable member is linearized into a single straight elongate conformable member in the hollow sleeve with the proximal end at one end of the sleeve and the caudal end at the other end of the sleeve and introduced proximal-end first from the sleeve into the uterine cavity to assume the predetermined three dimensional configuration; wherein said three dimensional configuration is capable of elastically contracting and expanding in response to contraction and expansion of said uterine cavity thereby enabling said three dimensional configuration to maintain its position within said uterine cavity and release said contraceptive agent therein. 
     
     
       9. The method according to  claim 8 , wherein one loop-like structure is positioned opposite a uterine fundus following emergence of said elongate member from said hollow sleeve. 
     
     
       10. The method of  claim 8 , wherein said three dimensional configuration has a diameter of about 10 mm to about 15 mm.